Methods and apparatus to deliver therapeutic, non-ultraviolet electromagnetic radiation to inactivate infectious agents and/or to enhance healthy cell growth via a catheter residing in a body cavity

ABSTRACT

Methods and apparatus provide therapeutic electromagnetic radiation (EMR) for inactivating infectious agents in, on or around a catheter residing in a patient&#39;s body cavity and/or for enhancing healthy cell growth. The method comprises transmitting non-ultraviolet therapeutic EMR substantially axially along an optical element in a lumen of the catheter body and/or the catheter body. Through delivery of the therapeutic EMR to particular infected areas and/or areas requiring tissue healing., The methods and apparatus of the present disclosure inactivate the major sources of infection in, on, and around catheters and/or enhance healthy cell growth around catheters.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/668,266, filed on Aug. 3, 2017 and entitled METHODS AND APPARATUS TODELIVER THERAPEUTIC, NON-ULTRAVIOLET ELECTROMAGNETIC RADIATION TOINACTIVATE INFECTIOUS AGENTS AND/OR TO ENHANCE HEALTHY CELL GROWTH VIA ACATHETER RESIDING IN A BODY CAVITY (hereinafter the “ParentApplication”), which is a continuation-in-part of U.S. patentapplication Ser. No. 13/801,750, filed on Mar. 13, 2013 and entitledMETHODS AND APPARATUS TO INACTIVATE INFECTIOUS AGENTS ON A CATHETERRESIDING IN A BODY CAVITY, now issued as U.S. Pat. No. 9,808,647 on Nov.7, 2017, which claimed the benefit of U.S. Provisional Application No.61/686,432 filed Apr. 5, 2012 and was entitled HINS LASER LIGHTCATHETER. The Parent Application is also a continuation-in-part of U.S.application Ser. No. 15/424,732, filed Feb. 3, 2017 and entitled METHODAND APPARATUS FOR REMOVABLE CATHETER VISUAL LIGHT THERAPEUTIC SYSTEM,which claimed the benefit of U.S. Provisional Application No. 61/686,432filed Apr. 5, 2012 and was entitled HINS LASER LIGHT CATHETER. Each ofthe related applications mentioned in this paragraph is herebyincorporated by this reference as if fully set forth herein.

TECHNICAL FIELD

The present invention is a method and apparatus to provide therapeuticdoses of non-ultraviolet light to inactivate infectious agents residingon, within, or generally around a catheter while the catheter isresiding within a body cavity and/or to stimulate healthy cell growthcausing a healing effect. In particular, the disclosure is a medicaldevice assembly that utilizes non-ultraviolet visual therapeuticelectromagnetic radiation (EMR) at a high enough intensity to stimulatehealthy cell growth causing a healing effect and/or to reduce oreliminate infectious agents in, on, and around a catheter while itresides inside a body cavity.

Various exemplary embodiments of the present invention are describedbelow. Use of the term “exemplary” means illustrative or by way ofexample only, and any reference herein to “the invention” is notintended to restrict or limit the invention to exact features or stepsof any one or more of the exemplary embodiments disclosed in the presentspecification. References to “exemplary embodiment,” “one embodiment,”“an embodiment,” “some embodiments,” “various embodiments,” and thelike, may indicate that the embodiment(s) of the invention so describedmay include a particular feature, structure, or characteristic, but notevery embodiment necessarily includes the particular feature, structure,or characteristic. Further, repeated use of the phrase “in oneembodiment,” or “in an exemplary embodiment,” do not necessarily referto the same embodiment, although they may.

BACKGROUND

Catheters are commonly used as channels to inject medications orretrieve fluid samples in a patient. Each catheter comprises a tube,usually derived from plastic or other polymers, such as silicone,polyurethane, and the like, that is inserted into an area of the bodyand may contain one or more separate lines in which these fluids may bedelivered or retrieved. A “lumen” designates a pathway in the catheterthat goes from outside the body to inside the body. Catheters are usedin various applications, including intravascularly, abdominally,urologically, gastrointestinally, ophthalmically, within the respiratorytract, within cranial space, within the spinal column, and the like. Inall cases, the catheter is placed inside of a space in the body wherethe catheter resides, herein referred to as a “body cavity”. Thesedevices frequently give rise to infections caused by growth ofinfectious agents in, on, and around the catheter. Infectious agents caninclude bacteria, fungi, viruses, or the like that enter the body andlead to illness of a patient. Depending on the location of the catheterplacement, these infections can arise in the form of urinary tractinfections, blood stream infections, soft tissue infection, and thelike.

Catheter related infections (CRIs) are a large problem in medicine,leading to high morbidity and mortality rates. Current methods ofreducing or eliminating the number of infectious agents in and on acatheter are of low efficacy. Typically, catheters will be removed ifthey are suspected to be harboring infectious agents, increasing boththe cost associated with treatment and patient discomfort. Variousmethods to deter or eliminate growth of infectious agents in cathetershave been attempted, such as using sterile handling techniques,antibiotics, and replacing the catheter when an infection is suspected.Despite these techniques, infections resulting from catheters remain amajor problem. According to the Centers for Disease Control andPrevention, over 31,000 people died specifically from catheter-relatedbloodstream infections in 2010. These infections, along with urinarytract infections, gastrointestinal infections, and other infections fromcatheters, increase both medical costs and patient discomfort.

Catheters come in various sizes. Those that are smaller in diameter,such as many PICC lines (peripherally inserted central catheters), havesmall diameter lumens. Such smaller diameter catheters may be suitablefor prolonged insertion. Consequently, with smaller diameter catheters,there may be inadequate thickness to the catheter wall to carry asterilization and/or healthy growth enhancing delivery system.

The use of ultraviolet (UV) light, disinfecting chemicals, cathetersimpregnated with drugs, to name a few, have been attempted to reduce theprevalence of infection. Many patents have attempted to utilize UV lightto disinfect catheters. Unfortunately, UV light is well known to causedamage to living cells. Methods to disinfect connectors, stopcocks, andvalves using sterilizing electromagnetic radiation (EMR) have also beenattempted using 405 nm light to sterilize these points, but thesemethods neglect disinfection of the catheter body as well as the tip ofthe catheter.

The emergence of infectious agents that are resistant to currenttreatments, such as methicillin-resistance staphylococcus aureus (MRSA),further substantiate the need for another treatment of CRIs. To reducethe costs associated with having to remove and replace the cathetersfrom the patient, there is a need for a catheter that can be sterilizedwhile residing in the patient. Additionally, it would be advantageous tobe able to stimulate healthy cell growth by providing therapeutic EMRvia the indwelling catheter.

Immediate disinfection after placement could help prevent the growth ofbiofilm on the catheter. Biofilm consists of extracellular polymericmaterial created by microorganisms after they adhere to a surface. Thisbiofilm facilitates the growth of infectious agents and is verydifficult to break down once it has begun to grow.

The growth of infectious agents can result from agents outside thepatient (at the point of access as the catheter crosses the skin or fromthe catheter hub) or from inside the patient, wherein infectious agentsalready in the body attach to the surface of the catheter andproliferate. Scientific literature suggests that approximately 65% ofCRI's come from infectious agents residing on the skin of the patient(S. Öncü, Central Venous Catheter—Related Infections: An Overview withSpecial Emphasis on Diagnosis, Prevention and Management. The InternetJournal of Anesthesiology. 2003 Volume 7 Number 1). These agents traveldown the outside of the catheter and colonize the catheter tip. Forshort term catheterization, this is believed to be the most likelymechanism of infection (Crump. Intravascular Catheter-AssociatedInfections. Eur J Clin Microbiol Dis (2000) 19:1-8). Thirty percent(30%) of CRIs are believed to come from a contaminated hub, in whichinfectious agents travel down the interior of the catheter (Öncü). Thisis believed to be the most likely mechanism of infection for long-termcatheterization (Crump).

EMR in the range of 380-900 nm has been shown to be effective in killinginfectious agents. Research done by a group at the University ofStrathclyde shows that light in this range is effective in killingsurface bacteria in burn wards without harming the patients(Environmental decontamination of a hospital isolation room usinghigh-intensity light. J Hosp Infect. 2010 Nov; 76(3):247-51). Publishedpatent application 2010/0246169, written by the members who conductedthe study, utilizes ambient lighting to disinfect a large surroundingarea. The mechanism proposed by the team suggests that light in thisrange leads to photosensitization of endogenous porphyrins within thebacteria, which causes the creation of singlet oxygen, leading to thedeath of the bacteria. (Inactivation of Bacterial Pathogens followingExposure to Light from a 405-Nanometer Light-Emitting Diode Array. ApplEnviron Microbiol. 2009 Apr; 75(7): 1932-7).

Heretofore, however, there has never been apparatus or methods formaking or using such apparatus to safely and effectively disinfect acatheter while it is still implanted in a patient. Accordingly, thereexists a need for a methods and apparatus designed to delivernon-antibiotic, bactericidal therapeutics in-vivo. Such a methods andapparatus, using novel technology, may provide removable delivery ofsafe, effective, and reproducible disinfection and/or enhance healthycell growth.

SUMMARY OF THE INVENTION

The exemplary embodiments of this disclosure relate to a medical deviceassembly for insertion into a cavity of a patient's body and fordelivery and retrieval of fluids. The assembly comprises anelectromagnetic radiation (EMR) source for providing non-ultraviolet,therapeutic EMR having intensity sufficient to inactivate one or moreinfectious agents and/or to enhance healthy cell growth. This catheterhas an elongate catheter body with at least one internal lumen, acoupling end, and a distal end. This distal end is insertable into thecavity of the patient's body whether the cavity is venous, arterial,gastrointestinal, abdominal, urological, respiratory, cranial, spinal,or the like, wherein the indwelling catheter body directs both the fluidand the propagation of the therapeutic EMR axially relative to thecatheter body for radial delivery into the patient's body and/or at thedistal end. An optical element disposed within a lumen of the catheterbody and/or within the catheter body acts conducive to the axialpropagation of the therapeutic EMR relative to the catheter body. Theoptical element or another optical element also may be disposed to actconducive to propagation of therapeutic EMR through at least onecoupling element to connect the EMR component to the insertable cathetercomponent.

For the purposes of this disclosure the use of the term “therapeutic”should be understood to mean of or relating to the treatment of disease,including reducing or eliminating infectious agents, as well as servingor performed to maintain health, including enhancing healthy cellgrowth.

The exemplary medical device assembly comprises an EMR source, an EMRconduction system, and at least one coupling to connect the EMR sourceto the EMR conduction system. The EMR source provides non-ultraviolet,therapeutic EMR having intensity sufficient to inactivate one or moreinfectious agents and/or to stimulate healthy cell growth causing ahealing effect. In at least one exemplary embodiment, the EMR conductionsystem may be at least partially insertable into and removable from thelumen of an indwelling catheter.

In some exemplary embodiments, methods and apparatuses are provided foreffectively sterilizing a catheter and the surrounding area while in abody cavity. Such medical device assemblies use sterilizing EMR toreduce or eliminate the count of infectious agents in, on, or around thecatheter while in a body cavity.

The EMR source can be from a single or group of EMR sources including,but not limited to, a light emitting diode, a semiconductor laser, adiode laser, an incandescent (filtered or unfiltered) and a fluorescent(filtered or unfiltered) light source. This EMR source providesnon-ultraviolet, therapeutic EMR providing one or more wavelengths inthe range of above 380 nm to about 904 nm. In order to providesufficient inactivation of infectious species and/or stimulation ofhealthy cell growth, each EMR wavelength should be of a narrow spectrumand centered around one wavelength from the group. The intensity shouldbe sufficient to inactivate one or more infectious agents and/or tostimulate healthy cell growth causing a healing effect. This groupincludes several wavelengths centered about: 400 nm, 405 nm, 415 nm, 430nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm, 632.8 nm, 640 nm,650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm.

The EMR source may require drivers and electronic support for fullfunctionality. Consideration should be given to accommodating thesupport hardware and/or software, which may encompass a significantportion of the EMR source's functionality and efficacy. It is possiblethat the EMR source may generate heat, which could be detrimental to theEMR source and may need to be limited.

This disclosure describes a catheter having an elongate catheter bodywith at least one internal lumen, a coupling end and a distal end, thedistal end being insertable into the cavity of the patient's body. Thecatheter body is meant to direct both the fluid and the therapeutic EMRaxially relative to the catheter body for delivery into the patient'sbody at the distal end. This disclosure includes an optical elementdisposed within the catheter body and conducive to the axial propagationof the therapeutic EMR through the catheter body. Finally, thisdisclosure describes at least one coupling element to connect theradiation source to the catheter body.

The sterilizing EMR is transmitted down a specialized path within thecatheter via an optical element conducive to the axial propagation ofthe light. Various methods could be used to facilitate axial propagationof the light relative to the catheter, including a reflective coatingwithin a line of the catheter, a fiber optic cable, a lens, a waveguide,or the like. The light source can be a light-emitting diode (LED),laser, fiber optic filament, or the like.

One exemplary embodiment of the EMR source and support components issimplified to contain only the EMR source and necessary components. Inanother exemplary embodiment of the EMR conduction system, a passiveheat sink is required to diffuse the heat generated into the surroundingenvironment. In yet another exemplary embodiment of the EMR source, aheat sink may be couple to at least one fan to actively dissipate heatgenerated by the EMR source.

Of particular interest to this disclosure is the use of light between380 nm and about 900 nm wavelengths. Additionally, the intensity andpower of the light emitted bear significantly on the inactivation ofinfectious agents, thus a range of radiant exposures covering 0.1 J/cm²to 1 kJ/cm² and a range of powers from 0.005 mW to 1 W, and powerdensity range covering 1 mW/cm² and 1 W/cm² are of interest for theseexemplary device assemblies and methods. These ranges of wavelengths,power densities, and radiant exposures have been shown to have eitherantimicrobial effects or positive biological effects on healing tissue.These positive biological effects include reduction of inflammatorycells, increased proliferation of fibroblasts, stimulation of collagensynthesis, angiogenesis inducement and granulation tissue formation.

For each exemplary embodiment described herein, the EMR conductionsystem and method for disinfection/healing could be utilized in anadjustable or predetermined duty cycle. If treatments begin immediatelyafter sterile procedure was initiated, device related infections may beinhibited. This includes device related biofilm growth.

A treatment may include at least one wavelength of therapeutic EMR thatacts as a predominant wavelength selected to sterilize one or moretarget organisms and selected from the group of wavelengths centeredabout 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm,475 nm, 660 nm, and 808 nm. Or, a predominant wavelength selected topromote healing and healthy cell growth may be selected from the groupof wavelengths centered about 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm,670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. Another treatmentmay include alternating the predominant wavelength between a firstpredominant wavelength and a second predominant wavelength (differingfrom the first predominant wavelength) in a selected treatment pattern.Further, sterilizing EMR and EMR that stimulates healthy cell growth maybe transmitted simultaneously in tandem or alternatively.

A method for constructing an exemplary medical device assembly forinsertion into a cavity of a patient's body and for delivery of a fluidto or retrieval from the patient's body may comprise the steps of:providing a catheter having an elongate catheter body with at least oneinternal lumen, a coupling end and an distal end, the distal end beinginsertable into the cavity of the patient's body; applying an opticalelement within the at least one lumen of the catheter body and/or withina wall of the catheter body, the optical element being conducive to theaxial propagation of therapeutic EMR relative to the catheter body; andcoupling an EMR source to the catheter body, the EMR source forproviding non-ultraviolet, therapeutic EMR having an intensitysufficient to inactivate one or more infectious agent and/or to enhancehealthy cell growth.

In one exemplary embodiment, the device uses a catheter that is insertedinto a cavity of a patient's body, wherein said catheter allows bothfluid and therapeutic EMR to travel axially relative to the catheterbody. The catheter also contains at least one coupling lumen to connectan EMR source that will transmit the therapeutic EMR through thecoupling lumen and axially relative to the catheter line. A couplingelement in this context will usually refer to a typical hub on thetherapeutic EMR source.

In at least one exemplary embodiment, a removably insertable EMRconduction system may comprise at least one optical element having anelongate body conducive to the axial propagation of the therapeutic EMRthrough the elongate body. This elongate body may have an exteriorsurface between a coupling end and a distal end. The exterior surfacemay have at least one radial emission portion wherein the radialemission facilitates the radial emission of therapeutic EMR from theelongate body proximate each radial emission portion.

At least one coupling connects the radiation source to the EMRconduction system and, in some exemplary embodiments, may comprise atleast one feature that allows for the coupling to be readily removablefrom the EMR conduction system. The exemplary coupling may be achievedby utilizing a uniquely designed connection, a pre-manufactured couplingsystem, or any combination thereof that optimizes the couplingefficiency and utility. Further, such couplings couple the removablyinsertable EMR conduction system to the EMR source and may comprise morethan one coupling with an intermediate section optimized to further thepropagation of the EMR. In one exemplary embodiment, the EMR source maybe coupled to a patch cable or EMR conduction extending segment, whichis then coupled to the formal removably insertable EMR conductionsystem.

The optical element further may comprise at least one optical featureselected from a group of optical features such as a reflective surface,an optically transmissible material, a lens, a fiber optic filament, andany combination thereof. The optical element also may be capable oftransmitting more than one wavelength or intensity EMR. Multiplewavelengths may be transmitted simultaneously, one after another or intandem, or a combination thereof (for example, one constantly on and theother wavelength pulsed). Multiple intensities may be transmittedthrough the same element simultaneously. Alternating patterns of lighttreatments may also be transmitted.

The EMR conduction system may be configured to insert, at leastpartially, into one of any number of catheters, such as by way ofexample only and not to be limiting: a central venous catheter, aperipheral insertion catheter, a peripheral insertion central catheter,a midline catheter, a jugular catheter, a subclavian catheter, a femoralcatheter, a cardiac catheter, a cardiovascular catheter, a urinary Foleycatheter (see FIGS. 13 and 14), an intermittent urinary catheter, anendotracheal tube, a dialysis catheter (whether hemodialysis orperitoneal dialysis), a gastrointestinal catheter, a nasogastric tube, awound drainage catheter, or any similar accessing medical catheter ortube that has been inserted into a patient for the purpose of deliveringor retrieving fluids or samples.

One exemplary embodiment of the EMR conduction system has an opticalelement comprising a single, insertable optical fiber. With a singleoptical fiber, the single fiber may allow light to transmit radially oraxially at various sections along its length. For sections where lightwill transmit radially, the exterior surface of the optical element maybe altered to facilitate the radial emission of the EMR. The alterationof the exterior surface may be achieved by chemical etching, physicaletching, or electromagnetic ablation through plasma or lasers to createvarious radial emission portions along the length of the optical fiber.The radial emission portions permit light to emit radially from theoptical fiber.

For purposes of this disclosure, light emitted radially means that thelight has a radial component. Hence, the light emitted radially may emitperpendicularly and/or obliquely to the central axis of the opticalfiber at the axial point of emission.

For embodiments having radial emission sections, the material comprisingthe optical fiber may be selected from a group of materials comprisingoptical fibers including plastic, silica, fluoride glass, phosphateglass, chalcogenide glass, and any other suitable material that iscapable of axial light propagation and surface alteration to achieveradial emission. In addition, the optical fibers may be single mode,multi-mode, or plastic optical fibers that may have been optimized foralteration using a chemical, physical, or electromagnetic manufacturingalteration process. The optical fibers may also be optimized foralteration post-production.

Yet another exemplary embodiment employs a physical abrasion method ofalteration to modify the EMR conduction system comprised of at least oneoptical fiber. This fiber would be utilized based on its optimal opticalresponse to the physical abrasion process. This process may include, butis not limited to, sanding, media blasting, grinding, buffing, or mediablasting at least one section of the optical fiber. The physicalabrasion process would also necessarily be optimized in terms of theextent of physical abrasion to optimize the appropriate radial EMRemission or lack thereof. This may be accomplished by adjusting at leastone of velocity, acceleration, pressure, modification time, or abrasionmaterial utilized in modifying the optical fiber.

Yet another exemplary embodiment employs microscopic porous structuressuspended within the optical fiber to achieve radial transmission oflight. These microscopic structures may be positioned within the coreand/or core-cladding boundary of the optical fiber. The microscopicstructures having a refractive index lower than the region free ofmicroscopic structures. The microscopic structures may be a materialadded to the optical fiber core or the core-cladding boundary, such as ametal, rubber, glass, or plastic. The microscopic structures may also bethe lack of material creating an aberration within the optical fibercore or the core-cladding boundary. For example, the presence ofmicroscopic bubbles in the optical fiber core would create an aberrationor imperfection that would alter the materials refractive index,resulting in EMR being emitted radially from the optical fiber.

Another exemplary embodiment may comprise at least one optical fiberwith cladding altered to optimize the radial or axial propagation ofEMR. For example, the cladding may be altered to at least partiallyremove or thin the cladding in order to achieve partial radialtransmission of EMR. Another example could include an optical fiber withonly certain portions containing cladding, the EMR transmitting axiallyin the clad portions and at least partially axially and radially in thenon-clad portions.

Yet another exemplary embodiment achieves uniform radial transmissionwherein the radial emission portion of the optical fiber hassubstantially equivalent intensity over the length of the radialemission portion along the optical fiber. This may be done throughchemical etching, physical etching, plasma ablation, or laser ablationin a gradient pattern. By altering at least one of velocity,acceleration, pressure gradients, flow, modification time, ormodification material or process, it is possible to achieve radialtransmission equivalency throughout each portion or the entire length ofthe modified optical fiber. During manufacturing, a gradient- provideduniformity also may be achieved through addition of microscopicstructures positioned within the core and/or core-cladding boundary in agradient pattern. Also, radial transmission uniformity achieved throughgradient cladding or core features are contemplated for achievingdesired radial emission, whether substantially uniform over a portionlength or varying as desired.

Still another exemplary embodiment achieves a gradient radialtransmission wherein at least one portion of the optical fiber emits EMRradially in a gradient distribution. The gradient distribution may alsobe accomplished through chemical etching, physical etching, plasma orlaser ablation in a uniform or gradient pattern. By altering at leastone of velocity, acceleration, pressure gradients, flow, modificationtime, or modification material or process, it is possible to achieve agradient radial transmission throughout a portion of the optical fiber.This may also be achieved through addition of microscopic structurespositioned within the core and/or core-cladding boundary.

A further exemplary embodiment of a removably insertable EMR conductionsystem comprises an optical element such as at least one LED, itsassociated wiring components, and a scaffold. The LED(s) may emit EMRbased on the LED's inherent distribution, or may utilize another opticalelement, such as a lens or mirror, to focus or diffuse the EMR in thedirection of interest. In addition, more than one LED could be arrangedin an array to appropriately emit EMR for maximal therapeutic benefit.The LED(s), together with associated wiring components may bepermanently or removably attached to the scaffold, which allows forremovable insertion of the EMR conduction system into a catheter. Thescaffold may be rigid, semi-rigid, malleable, elastic, or flexible, orany combination thereof.

In another exemplary embodiment, a catheter with multiple lumens forfluid injection or retrieval contains a separate lumen for transmissionof the therapeutic EMR. Each lumen may have a separate proximal catheterhub assembly. These internal lumens converge at a convergence chamber,where individual internal lumens consolidate into a single elongatedcatheter body while retaining their individual internal paths. Suchexemplary device may include use of an optical method for diverting theradiation between the convergence chamber and axially through thedesignated catheter internal lumen.

Samples retrieved through the distal end are often used to characterizethe type of infection. One exemplary embodiment of the disclosurefocuses on maintaining axial propagation of the light relative to thecatheter and delivering therapeutic light of sufficient intensity to thedistal end of the catheter to reduce or eliminate the count ofinfectious agents residing thereon.

In yet another exemplary embodiment, the medical device assemblyaforementioned would be used in a urological setting. The catheter (suchas a Foley catheter) would be placed into the urethra and bladder of theurinary tract.

In yet another exemplary embodiment, the medical device assemblyaforementioned would be used in a gastrointestinal setting.

In yet another exemplary embodiment, the medical device assemblyaforementioned would be used in an intravascular setting.

In yet another exemplary embodiment, the medical device assemblyaforementioned would be used within the cranial cavity of a patient.

In yet another exemplary embodiment, the medical device assemblyaforementioned would be used within the spinal cavity of a patient.

In still another exemplary embodiment, the medical device assemblyaforementioned would be used within an ophthalmic cavity of a patient.

In still another exemplary embodiment, the medical device assembly wouldbe used within a dialysis catheter (whether hemodialysis or peritonealdialysis).

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the invention will become more fully apparentfrom the following description and appended claims, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly exemplary embodiments and are, therefore, not to be consideredlimiting of the invention's scope, the exemplary embodiments of thepresent disclosure will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1 is a perspective view of an exemplary embodiment of a doublelumen catheter and an EMR component with the connection in an explodedview to illustrate the connection of the EMR source to the catheter;

FIG. 2 is a schematic view of another exemplary embodiment of a tunneledtriple lumen catheter as inserted into a body cavity through an insertincision in the patient's chest;

FIG. 3 is a schematic view of yet another exemplary embodiment of atunneled triple lumen catheter, an insertable optical element, and anEMR component, showing the triple lumen catheter as inserted into a bodycavity through an insert incision in the patient's arm and theconnection in an exploded view to illustrate the connection of the EMRsource to the catheter and the insertion of the optical elementpartially inserted into the catheter;

FIG. 4 is a perspective, partially exploded view of still anotherexemplary embodiment of a dual lumen catheter with the insertableoptical element disposed outside the catheter and showing anintermediate coupling;

FIG. 5 is a perspective view of the exemplary dual lumen catheter ofFIG. 4 with the insertable component disposed partially inside thecatheter;

FIG. 6A is a cross sectional view along line B-B of FIG. 5 showing anexemplary embodiment of a cladding-encased optical element as centeredwithin a lumen of the catheter line tubing;

FIG. 6B is a cross sectional view along line B-B of FIG. 5 showing anexemplary embodiment of the cladding-encased optical elementnon-centered within a lumen of the catheter line tubing;

FIG. 6C is a cross sectional view along line B-B of FIG. 5 showinganother exemplary embodiment of a bare fiber optical element as centeredwithin a lumen of the catheter line tubing (FIGS. 6A-C are illustrativecross-sectional views of alternative optical elements as disposed withina single-lumen catheter);

FIG. 7 is a perspective, partially exploded view of an exemplary duallumen catheter with the insertable component disposed partially insidethe catheter and showing an intermediate coupling;

FIGS. 8A-D is a series of elevation views of several exemplaryembodiments of an insertable optical element with varying locations,lengths, and degrees of alteration, and with an optical elementconnector shown as transparent to better illustrate internal featuresthat are shown in phantom lines; FIG. 8A is an elevation view of anexemplary embodiment of an optical element having no radial emissionportion; FIG. 8B is an elevation view of another exemplary embodiment ofan optical element having a single radial emission portion disposed overan intermediate segment between the coupling end and the distal end ofthe optical element; FIG. 8C is an elevation view of yet anotherexemplary embodiment of an optical element having a single radialemission portion disposed over substantially the entire distance betweenthe coupling end and the distal end of the optical element; FIG. 8D isan elevation view of still another exemplary embodiment of an opticalelement having multiple radial emission portions, one disposed over anintermediate segment between the coupling end and the distal end of theoptical element, and another proximate the distal end.

FIG. 9 shows cross-sectional views of multiple portions of an exemplaryinsertable optical element (similar to that shown in FIG. 8C) withvarious EMR radial, gradient emission levels;

FIG. 10 shows the cross-sectional views of various gradient emissionlevels of FIG. 9 showing the sections with EMR ray diagrams of internalreflection, and relative radial emission;

FIG. 11 shows cross-sectional views of various exemplary dispersals ofmicroscopic structures (such as flecks or bubbles) within a fiberoptic's core, cladding, and the core/cladding boundary;

FIG. 12 is a schematic view of a treatment being applied to theinsertable optical element distal end;

FIG. 13 is a perspective, partially exploded view of an exemplaryembodiment of a urinary catheter with the insertable optical elementshown partially inserted into an input port and the ballon cuffinflated; and

FIG. 14 is a schematic view of another exemplary embodiment of a urinarycatheter positioned to drain urine and to provide therapeutic EMR.

REFERENCE NUMERALS catheter 10 patient's body 12 optical element 14 linetubing 16 EMR conduction system 18 electromagnetic radiation component20 insertable catheter component 22 elongate body 24 electromagneticradiation power source 26 coupling element 28 internal lumen 30 proximalcatheter hub assembly 32 distal end 34 aperture 35 elongate catheterbody 36 balloon cuff 37 catheter of varying lengths 38 urethra 39convergence chamber 40 bladder 41 termination of the optical element 42input port 43 flexible protection tubing 44 output port 45 line clamp 46transdermal area 48 optical assembly 50 intermediate coupling 52 patchcable 54 EMR conduction extending segment 56 forward connector 58rearward connector 60 exterior surface 62 distal end 64 core 66 cladding68 cladding-encased fiber optic 70 bare fiber optic 72 inner diameter 74outer diameter 76 void 78 core-cladding boundary 80 cladding outerboundary 82 catheter wall 84 connecting element 88 EMR hub connector 90collimating lens 92 optical element connector 94 alignment shaft 98 analigning bore 99 non-modified optical span 100 segment-modified opticalspan 102 radial emission portion 103 fully-modified optical span 104elongated radial emission portion 105 multi-modified optical span 106modified tip portion 107 first section 108 microscopic structures freearea 109 second section 110 minimal concentration 111 third section 112moderate concentration 113 fourth section 114 maximal concentration 115microscopic structures 117 first dispersal 121 control device 122 seconddispersal 123 wand 124 third dispersal 125 acid spray 126 outer region127 inner region 129 boundary region 131 adapter 150 securing sleeve 152drain tube 154 operational control features 156 display 158 optical jack160 fluid flow/EMR propagation 162 urine flow 164 insertion site A

DETAILED DESCRIPTION

Exemplary embodiments of the present disclosure will be best understoodby reference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the exemplary embodiments, as generally described and illustrated inthe Figures herein, could be arranged and designed in a wide variety ofdifferent configurations. Thus, the following more detailed descriptionof the exemplary embodiments of the apparatus, system, and method of thepresent disclosure, as represented in FIGS. 1 through 11, is notintended to limit the scope of the invention, as claimed, but is merelyrepresentative of exemplary embodiments.

The phrases “attached to”, “secured to”, and “mounted to” refer to aform of mechanical coupling that restricts relative translation orrotation between the attached, secured, or mounted objects,respectively. The phrase “slidably attached to” refer to a form ofmechanical coupling that permits relative translation, respectively,while restricting other relative motions. The phrase “attached directlyto” refers to a form of securement in which the secured items are indirect contact and retained in that state of securement.

The term “abutting” refers to items that are in direct physical contactwith each other, although the items may not be attached together. Theterm “grip” refers to items that are in direct physical contact with oneof the items firmly holding the other. The term “integrally formed”refers to a body that is manufactured as a single piece, withoutrequiring the assembly of constituent elements. Multiple elements may beformed integral with each other, when attached directly to each other toform a single work piece. Thus, elements that are “coupled to” eachother may be formed together as a single piece.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

Referring now to FIG. 1, a catheter 10 is insertable into a patient'sbody 12. An assembly of the present disclosure comprises anon-ultraviolet, electromagnetic radiation (EMR) component 20, and aninsertable catheter component 22. The non-ultraviolet, EMR component 20broadly comprises an elongate body 24 used to enclose the EMR powersource 26 and a coupling element 28 to couple the two components of theassembly. The EMR used manifests as visible light emitted in a rangefrom 380 nm to 904 nm having a high intensity sufficient to create atherapeutic effect such as inactivating one or more infectious agentsand/or enhancing healthy cell growth. In some embodiments, the EMRsource 26 has an adjustable duty cycle length so that the EMR can beprovided with appropriate desired intensity at the most effective timesand for beneficial time periods.

The catheters 10 depicted in FIGS. 1-5 are exemplary multiple lumencatheters 10 each of which also comprises line tubing 16, one or more(in FIGS. 1, 4, and 5 two are shown, in FIGS. 2 and 3, three are shown)proximal catheter hub assemblies 32, an elongate catheter body 36, adistal end 34 with one or more apertures 35 that open into internallumens 30, and a convergence chamber 40. Each internal lumen 30 has aninner diameter (i.e., an interior surface dimension, for example seeouter diameter 76 of FIG. 6A) and runs the length of the catheter 10,from the proximal catheter hub assembly 32, through the line tubing 16,the convergence chamber 40, and the elongate catheter body 36, to thedistal end 34. Fluids may be injected into the lumen 30 and exit throughthe aperture 35 into the patient's body 12, or fluids may be drawn fromthe patient's body 12 through the aperture 35 into the lumen 30.Additionally, some catheters 10 may have inflatable balloon cuffs 37(see FIGS. 13 and 14) that may seal the catheter 10 against the wall ofthe patient's body 12 cavity into which the catheter 10 is inserted. Theoptical element 14 is elongate may be a reflective coating or it may bea fiber optic with an outer diameter (i.e., an exterior surfacedimension, for example see outer diameter 76 of FIG. 6A) sufficientlysmall to be insertable within at least one of the internal lumens 30 andmay extend at least as far into the catheter 10 as a termination of theoptical element 42, although the insertion may be less than that lengthif desired.

Catheters 10 suitable for use with an insertable optical element 14 maybe of several different makes, sizes, and functions. For example, aurinary catheter 10 (see FIGS. 13 and 14) inserted through a patient'surethra 39 into a patient's bladder 41 may have an input port 43, anoutput port 45, and an inflatable balloon cuff 37 to facilitate drainingurine from the patient's bladder 41 while permitting fluids (or in thecase of the present disclosure therapeutic EMR) to be injected into thepatient's body 12. As another example, catheters 10 that are translucentmay be particularly suited to permit the passage of radially emitted EMRthrough the catheter wall 84 (see an exemplary catheter wall 84 in FIGS.6A-C) to the tissue surrounding the catheter 10. Catheters 10 that havean interior surface dimension (inside diameter 74) sufficiently largerthan the exterior surface dimension (outer diameter 76) of theinsertable optical element 14 create a void 78 or passageway (see FIGS.6A-C) that may permit the injection or withdrawal of fluid (liquid orgas) simultaneously through the catheter 10 while that insertableoptical element 14 resides within the catheter 10.

Also, some catheters 10 have radiopacifiers embedded within the walls ofthe catheter 10 so that an image of where the catheter 10 is locatedwithin the patient's body 12 may be determined. However, some catheters10 have no such radiopacifiers. In either case, it is contemplated bythis disclosure that radiopacifiers may be contained in or on theinsertable optical element 14 to provide detection of the location ofthe catheter 10 within the patient's body 12 when the catheter 10 doesnot have radiopacifiers, and to provide detection of the location of theinsertable optical element 14 disposed within the catheter 10 whether ornot the catheter 10 has radiopacifiers (this may require differingradiopacifiers in some instances so that the catheter 10 and theinsertable optical element 14 may be distinguished).

With some exemplary embodiments, at least one of the proximal catheterhub assemblies 32 may have an optical fiber element alignment shaft 98that aligns an optical element connector 94 and the insertable opticalelement 14.

FIGS. 2 and 3 show the catheter 10, in a schematic view, inserted at aninsertion site A in the chest of the patient's body 12 (FIG. 2) and inan arm of the patient's body 12 (FIG. 3), respectively. The depictionshows how non-ultraviolet, therapeutic EMR may be delivered at theinsertion site A and to other sites within the patient's body 12. At theinsertion site A, the therapeutic EMR may be delivered to a transdermalarea 48 to inactivate infectious agents in that area and to enhancehealing of the insert site A. Similarly, proximate the distal end 34, inthis case within the vena cava, therapeutic EMR may be delivered toinactivate infectious agents and/or to enhance healing in that proximatevicinity.

Referring specifically to FIG. 2 of the present disclosure, a schematicview of another embodiment of the medical device assembly comprises anon-ultraviolet, EMR component 20, and an insertable catheter component22. The embodiment shown is specifically a tunneled triple lumen centralline variation of the disclosure; however it should be understood thatthe catheter may encompass any type of accessing catheter 10 (e.g.,vascular, gastrointestinal, etc.) without departing from the scope andspirit of the invention. The non-ultraviolet EMR component 20 is coupledto the proximal catheter hub assembly 32 of the insertable cathetercomponent 22. The other coupling hubs 32 are available for axialpropagation of fluid (whether by injection or retrieval). Eachdesignated internal lumen 30 propagates the EMR or fluid between itsproximal catheter hub assembly 32 and distal end 34.

Although the triple lumen catheters 10 of FIGS. 2 and 3 depict specificuses of the triple lumen catheter 10, it should be understood that atriple lumen embodiment may be a desirable option in areas wheremultiple fluid delivery or extraction is necessary simultaneously. Forexample, in hemodialysis, venous and arterial blood is exchangedsimultaneously. Similarly, in peritoneal dialysis, fluids and dissolvedsubstances (electrolytes, urea, glucose, albumin, and other smallmolecules) are exchanged from the blood by catheter access throughperitoneum in the abdomen of a patient. This exemplary triple lumenembodiment allows for the delivery of therapeutic EMR simultaneouslywith such dialysis function.

The incision site A and the proximate transcutaneous region of theinsertable catheter body 36 is often a high source of infections. Toreduce infections at this site and in this region, a dedicated area 48is a region that facilitates radial emission of the therapeutic EMR fromthe optical element 14 within the elongate catheter body 36. This allowsthe sterilizing EMR to irradiate outward and inactivate the infectiousagents at the insertion site A and transcutaneous in that region.

Proximate the distal end 34 of the elongate catheter body 36, theoptical element 14 discontinues at termination point 42 so that thetherapeutic EMR can irradiate throughout the distal end 34 of thecatheter 10 and the surrounding cavity area.

The EMR component 20 comprises the EMR power source 26 (FIGS. 2-5), alight source (not shown, such as a laser or the like), electricalcircuitry (not shown), and optics (not shown, but dependent upon thelight source) all housed within an elongate body 24. A coupling element28 connects the EMR component 20 to an optical assembly 50. The opticalassembly 50 comprises the insertable optical element 14 and the opticalelement connector 94. The combination of the EMR component 20, thecoupling element 28, and the optical assembly 50, comprising theinsertable optical element connector 94 and the insertable opticalelement 14, will be referred to herein as an EMR conduction system 18.In some embodiments, the EMR conduction system 18 is removable from itsinserted disposition within the catheter 10. When the EMR conductionsystem 18 is insertably removable, therapeutic EMR may be directed intoan existing indwelling catheter 10 in a retrofit context.

Of particular interest to each of the embodiments is the use of lighthaving wavelengths ranging from above 380 nm and about 904 nm.Additionally, the intensity and power of the light emitted server toinactivate of infectious agents and/or to promote healing. A range ofradiant exposures covering 0.1 J/cm² to 1 kJ/cm² and a range of powersfrom 0.005 mW to 1 W, and power density range covering 1 mW/cm² and 1W/cm² are of interest for these exemplary device assemblies and methods.These ranges of wavelengths, power densities, and radiant exposures havebeen shown to have either antimicrobial effects or positive biologicaleffects on healing tissue. These positive biological effects includereduction of inflammatory cells, increased proliferation of fibroblasts,stimulation of collagen synthesis, angiogenesis inducement andgranulation tissue formation.

For each exemplary embodiment described herein, the EMR conductionsystem 18 and method for disinfecting/healing could be utilized in anadjustable or predetermined duty cycle. If treatments began immediatelyafter sterile procedure has been initiated, device-related infectionsmay be inhibited. This includes device-related biofilm growth.

Additionally, although a wavelength in a range from 380 nm to 904 nmwith a sufficient intensity will inactivate one or more infectiousagents and/or enhance healthy cell growth, more precise wavelengths mayhave more particular efficacy against certain infectious agents or for adesired healing purpose. It has been determined that sterilizing EMR ofwavelengths including wavelengths centered about 400 nm, 405 nm, 415 nm,430 nm, 440 nm, 455 m, 470 nm, 475 nm, 660 nm, and 808 nm haveparticular efficacy. A wavelength selected to promote healing andhealthy cell growth may be selected from the group of wavelengthscentered about 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm,780 nm, 808 nm, 830 nm, and 904 nm.

The insertable catheter component 22, being capable of at leastpartially being inserted into a cavity of the patient's body 12 todeliver the non-ultraviolet, therapeutic EMR, comprises of at least oneinternal lumen 30, a proximal catheter hub assembly 32, and a distal end34. An internal lumen 30 being simply defined as the internal path bywhich fluid or EMR may travel. In cases of a single or multi-lumencatheter 10, similar features in the drawings will be labeled with thesame number. It should be noted that examples of multi-lumen cathetersare described and depicted in the parent application (U.S. applicationSer. No. 13/801,750, filed on Mar. 13, 2013) which has been incorporatedinto this application by a specific reference above. In multi-lumenembodiments, a dedicated single lumen may also be designated for theaxial propagation of EMR and each additional lumen dedicated for theinjection or retrieval of fluid axially. In this way both fluid and EMRcan be axially propagated simultaneously through their individual linesand the EMR-delivering optical element 14 and fluids need not occupy thesame lumen.

The distal end 34 being insertable into the cavity of the patient's body12 at a determined incision site A, enables the elongate catheter body36 to direct the delivery and/or retrieval of fluid and the therapeuticEMR axially relative to the elongate catheter body 36 for delivery intothe patient's body 12. The elongate catheter body 36 is described asbeing an elongated catheter 10 having at least one internal lumen 30.Another embodiment of the present disclosure is depicted in FIG. 4,showing a perspective view of a dual lumen catheter 10 with theremovable EMR conduction system 18 outside the catheter 10. The catheter10 portion of the depiction shows flexible protection tubing 44 thatprotects the coupling of the proximal catheter hub assembly 32 with theline tubing 16 and also protects line tubing 16 from wear imposed byline clamps 46.

Therapeutic EMR will travel axially relative to the catheter 10 whichmay be of varying lengths 38 depending on its specific need. The fluidspassing through the internal lumen 30 may be injected and containpharmacological compounds (e.g., a drug) or may be retrieved biologicalfluids (e.g., blood, urine, or cerebral spinal fluid).

This figure depicts a multi-lumen embodiment of the disclosure. Eachmulti-lumen embodiment may contain a convergence chamber 40, at thepoint where individual internal lumens 30 converge into a singleelongated catheter body 36 while retaining their individual internalpaths. At the distal end 34 of the elongate catheter body 36, theoptical element 14 discontinues at the termination point 42 so that thetherapeutic EMR can irradiate throughout the distal end 34 of thecatheter 10 and surrounding cavity area.

This embodiment also is fitted with flexible protection tubing 44 toprotect the lumen at the proximal catheter hub assembly 32 and betweenthe proximal catheter hub assembly 32 and convergence chamber 40. Ifmanual line occlusion is necessary it may be performed with the lineclamp 46.

FIG. 5 shows the dual lumen catheter 10 of FIG. 4 with the removablyinsertable EMR conduction system 18 partially inserted into one of thelumens 30 of the catheter 10.

FIG. 7 shows an exploded perspective view of an exemplary EMR conductionsystem 18 as partially inserted into the proximal catheter hub assembly32 and an internal lumen 30. With this exemplary embodiment, anintermediate coupling 52 is shown. Such intermediate coupling 52 maycomprise a patch cable 54 or an EMR conduction extending segment 56 usedto extend the distance between the EMR power source 26 and the opticalelement connector 94 of the insertable optical element 14, withoutappreciable loss of light intensity. Each of the patch cable 54 or EMRconduction extending segment 56 may have a forward connector 58 tosecurely engage coupling element 28, and a rearward connector 60 tosecurely engage the optical element connector 94. Hence, by using apatch cable 54 or an EMR conduction extending segment 56, the EMR powersource 26 may be operated some desired distance from the patient toreduce noise or heat concerns and/or to position the EMR power source 26closer to a power source (not shown) such as an electrical outlet orbattery pack.

FIGS. 6A-C is a series of illustrative cross-sectional views ofalternative optical elements 14 as disposed within an exemplarysingle-lumen catheter 10. Of course, multi-lumen catheters 10 are alsocontemplated by this disclosure and the context of FIGS. 6A-C can easilybe understood by those skilled in the art to apply equally tomulti-lumen catheters 10 wherein one or more optical elements 14 mayreside within one or more of the multiple lumens 30. The depiction ofsingle lumen catheter 10 cross sections is provided in the interest ofbrevity. However, examples of multi-lumen catheters are described anddepicted in the parent application (U.S. application Ser. No.13/801,750, filed on Mar. 13, 2013) which has been incorporated intothis application by a specific reference above.

FIG. 6A is a cross sectional view along line B-B of FIG. 5 showing anexemplary embodiment of a cladding-encased fiber optic 70 as centeredwithin a lumen 30 of the catheter line tubing 16. However, FIG. 6A mayalso depict a cross section of a single lumen catheter 10. The singlelumen line tubing 16/catheter 10, depicted in cross section, has aninner diameter 74 and a catheter wall 84. The cladding-encased fiberoptic 70 is an optical element 14 and has an outer diameter 76, acore-cladding boundary 80 and a cladding outer boundary 82. When thecladding-encased fiber optic 70 is centered, as depicted in FIG. 6A, anannular void 78 is created between the cladding outer boundary 82 andthe catheter wall 84 when the inner diameter 74 of the catheter wall 84is larger than the outer diameter 76 of the cladding-encased fiber optic70. Fluids may travel through this void 78, whether by injection orretrieval, when the cladding-encased fiber optic 70 resides within thelumen 30 of a single lumen catheter 10 (or a EMR designated lumen 30within a multi-lumen catheter 10.

FIG. 6B is a cross sectional view along line B-B of FIG. 5 showing anexemplary embodiment of the cladding-encased fiber optic 70 non-centeredwithin a lumen 30 of the catheter line tubing 16. Similarly, FIG. 6B mayalso depict a cross section of a single lumen catheter 10. However, thevoid 78 formed within the lumen 30 is not annular, and without structureto hold the cladding-encased fiber optic 70 in a centered disposition,the non-centered disposition may occur when the optical element 14 isremovably inserted into the lumen 30 of the catheter 10. Consequently,the therapeutic EMR emitted radially from the optical element 14 mustpass through the void 78 before reaching and passing through thecatheter wall 84. Especially when there is fluid present within the void78, the intensity of the therapeutic EMR may need to be increased sothat the therapeutic EMR emerging from the catheter wall 84 issufficient to inactivate infectious agents and/or to enhance healthycell growth in the tissue surrounding the indwelling catheter 10.

FIG. 6C is a cross sectional view along line B-B of FIG. 5 showinganother exemplary embodiment of a bare fiber optic 72 as centered withina lumen 30 of the catheter line tubing 16. With this embodiment, thevoid 78 is created between the catheter wall 84 and the exterior surface62 of the bare fiber optic 72.

FIGS. 8A-D is a series of elevation views of several exemplaryembodiments of an optical assembly 50 showing various locations withgradient degrees of alteration on the exterior surface 62 of theinsertable optical element 14. Each view of the series of views shows anoptical assembly 50 with an insertable optical element 14 connected tothe optical element connector 94. The optical element connector 94 (seealso FIGS. 7 and 9) has a connecting element 88, an EMR hub connection90, a collimating lens 92, and an alignment shaft 98.

The first view (uppermost, FIG. 8A) of the series of views shows anunaltered optical span 100 of the insertable optical element 14 that iswithout any radial dispersion (i.e., the insertable optical element 14has not been treated or altered to provide radial emission of light fromthe body of the insertable optical element 14). With this embodiment,therapeutic, non-ultra-violet EMR may be provided to a distal end 64 ofthe optical element 14 with no radial emission from the optical span 100other than at the distal end 64.

The second view (next view down, FIG. 8B) of the series of views showsan exemplary radial transmission equivalency over a radial emissionportion 103 (i.e., radial emission portion 103, as depicted, has agradient modification such that the emitted EMR has substantiallyuniform intensity and power over the length of the radial emissionportion 103) that provides radially dispersed light from asegment-modified optical span 102. The location of the single radialemission portion 103, in this instance, corresponds to where thecatheter 10 enters the insertion site A when the insertable opticalelement 14 is inserted fully into the catheter 10. With this embodiment,radially emitted visual light may sterilize and/or enhance healthy cellgrowth at the insertion site A and the transdermal area 48 or any otherpredetermined site within the patient's body 12.

Each of the views in FIGS. 8B-D depicts a gradient modification tofacilitate emitting EMR in a pattern wherein there is substantiallyuniform intensity and power over the length of the radial emissionportion(s). It should be understood, however, that although each of theviews depict EMR of uniform intensity and power, any desired pattern ofEMR emission may be achieved by varying the degree of modificationwithin the radial emission portion because less ablation will permitless radial emission of EMR and more ablation will permit more radialemission of EMR. For example, a radial emission portion with lessoblation proximate each end and more ablation in the middle will emitEMR of lesser intensity and power on each end with more intensity andpower emitting in the middle. Hence, any desired pattern of EMR emissionmay be created by adjusting the pattern of ablation within the radialemission portion.

The third view of the series of views (FIG. 8C) shows an example of asingle radial emission portion 105 that provides radially dispersed EMRfrom optical element 14 extending along most of a fully-modified opticalspan 104. The location of the single radial emission portion 105corresponds generally to the entire length of the insertable cathetercomponent 22 of the catheter 10. With this embodiment, therapeutic EMRmay be provided for substantially the entire length that the catheter 10that would be inserted within the patient's body 12.

The fourth view of the series of views (FIG. 8D) shows an example ofradial transmission uniformity at multiple locations. A single radialemission portion 103 and an additional distal end region radial emissionportion 107 are spaced along a multi-modified optical span 106. Thelocations of the radial emission portion 103 and the distal end regionradial emission portion 107 correspond to areas of the body, includingfor example the insertion site A, where the delivery of non-ultraviolet,therapeutic EMR may be desired for sterilization and/or healing. Itshould be understood that there may be more than one radial emissionportion 103 disposed along the length of the multi-modified optical span106 and/or each radial emission portion 103 may be distinct from eachother radial emission portion 103 and each may have differing lengths.

Also, it should be understood that in each of these views the radialemission portions depicted may be of modifications other thanmodification of the exterior surface 62 of the insertable opticalelement 14, such as for example, modifications including microscopicstructures embedded within the insertable optical element 14 that allowradial transmission of light from the insertable optical element 14.Further, such radial emission portions 103, 105, 107 may have gradientpatterns that allow for an overall substantially-uniform distribution oflight over the length of each radial emission portion 103, 105, 107.

FIG. 9 is a schematic view of an optical assembly 50 with an insertableoptical element 14 coupled to an optical element connector 94. Theinsertable optical element 14 has a fully-modified optical span 104.Multiple locations along the insertable optical element 14 are shown inenlarged cross-sectional views. These locations are axially spaced alongthe insertable optical element 14 to assist in describing the nature ofan exemplary insertable optical element 14 at each location. Asdepicted, there are four section locations, a first section 108, asecond section 110, a third section 112, and a fourth section 114. Forbrevity, the modifications on and in the insertable optical element 14at each of the four sections are combined in the depictions of FIG. 9.Of course, the radial emission portions of the insertable opticalelement 14 may be singular or multiple, may be any length or gradient,and may be coincident, overlapping or not.

The first section 108 represents an internally reflected region of theinsertable optical element 14. As shown at the first section 108, thereis no ablation (or other modification) and no microscopic structurewithin the core 66 of the insertable optical element 14. No therapeuticnon-ultraviolet EMR will emit radially from the insertable opticalelement 14 at the first section 108.

The second section 110 represents a minimally emissive region of theinsertable optical element 14. As shown at the second section 110, thereis minimal ablation (or other modification) to the exterior surface 62of the insertable optical element 14 and a minimal dispersal ofmicroscopic structures 117 within the core 66 of the insertable opticalelement 14. From the second section 110, minimal therapeutic,non-ultraviolet EMR will emit radially from the insertable opticalelement 14. However, the amount of EMR emitted should have sufficientintensity and power to inactivate infectious agents and/or promotehealing proximate the second section 110.

The third section 112 represents a moderately emissive region of theinsertable optical element 14. As shown at the third section 112, thereis moderate ablation (or other modification) to the exterior surface 62of the insertable optical element 14 and moderate dispersal ofmicroscopic structures 117 within the core 66 of the insertable opticalelement 14. From the third section 112, a moderate amount oftherapeutic, non-ultraviolet EMR will emit radially from the insertableoptical element 14 proximate the third section 112. However, prior toreaching the third section 112, the amount of light traveling axiallyalong the insertable optical element 14 diminishes due to the radialemission of some of the light such as at second section 110.Consequently, the degree of the gradient of modification is selected sothat the amount of EMR emitted radially at third section 112 should besubstantially uniform with the radial emission at the second section110. Hence, the intensity and power of the EMR emitted may besubstantially uniform with the intensity and power emitted at secondsection 110 and is of sufficient intensity and power to inactivateinfectious agents and/or promote healing.

The fourth section 114 represents a maximally emissive region of theinsertable optical element 14. As shown at the fourth section 114, thereis maximal ablation (or other modification) to the exterior surface 62of the insertable optical element 14 and maximal dispersal ofmicroscopic structures 117 within the core 66 of the insertable opticalelement 14. From the fourth section 114, a maximum amount oftherapeutic, non-ultraviolet EMR will emit radially from the insertableoptical element 14 proximate the fourth section 114. Again, prior toreaching the fourth section 114, the amount of light continuing totravel axially along the insertable optical element 14 diminishes due tothe radial emission of some of the light such as at second section 110and at third section 112. Consequently, the degree of the gradient ofmodification is selected so that the amount of EMR emitted radially atfourth section 114 should be substantially uniform with the emissions atsecond section 110 and third section 112. The intensity and power of theEMR emitted may be substantially uniform with the intensity and poweremitted at second section 110 and third section 112 and is of sufficientintensity and power to inactivate infectious agents and/or promotehealing.

The radial emission portions may be modified by chemical, physical orother cladding modification (e.g., ablation) to alter the critical angleenough to allow light to emit radially. Additionally or alternatively,the radial emission portions may be modified by dispersing microscopicstructures 117 of varying gradient concentration inside the core 66 ofthe insertable element 14. The gradient concentration of microscopicstructures 117 within the core 6 shown in FIG. 9 range from amicroscopic structures free area 109, to a minimal concentration 111 ofmicroscopic structures 117, to a moderate concentration 113 ofmicroscopic structures 117, to a maximal concentration 115 ofmicroscopic structures 117.

The concentration of microscopic structures 117 within the core 66affects the refractive index of the core 66 and the core-claddingboundary 80. The microscopic structures 117 (which may be, for example,reflective flakes or voids, such as bubbles) create changes in theincident angle of the light as it passes through the insertable opticalelement 14. At certain incident angles, light leaves the optical elementcladding 68 and emits radially from the cladding outer boundary 82.

FIG. 10 is a schematic view of the cross-sectional views of FIG. 9depicting light rays as arrows. The same cross-sectional views of theinsertable optical element 14 are shown: namely, the first section 108(internally reflected), the second section 110 (minimally radiallyemissive), the third section 112 (moderately radially emissive), and thefourth section 114 (maximally radially emissive). These views also showlight rays traveling axially along the core 66, that collide withmicroscopic structures 117 at an incident angle causing the light ray topass through the optical element cladding 68. An increasing pixilatedgradient is depicted on the cladding boundary 82 from the first section108 (no pixilation), to the second section 110 (minimal pixilation), tothe third section 112 (moderate pixilation), to the fourth section 114(maximal pixilation) represents the chemical, physical or other claddingmodification (e.g., ablation) at the cladding boundary 82. Suchmodification of the insertable optical element 14 alters critical anglesenough to allow light to emit radially. As schematically depicted, theamount of rays leaving the optical element cladding 68 are substantiallyequivalent at each site although the amount of rays the core 66diminishes as the light travels from proximal to distal. The microscopicstructures 117 of varying gradient concentration are also shown insidethe core 66, from the microscopic structure free area 109, to a minimalconcentration 111, to a moderate concentration 113, to a maximalconcentration 115. Each of the microscopic structures 117 has arefractive index that differs from that of the core 66 and the opticalelement cladding 68. The microscopic structures 117 (which may be, forexample, reflective flecks or voids, such as bubbles) create changes inthe incident angle of the light as it passes through the insertableoptical element 14. At certain incident angles, light leaves the opticalelement cladding 68 and emits radially.

FIG. 11 shows cross-sectional views of various exemplary dispersals ofmicroscopic structures 117 (such as flecks or bubbles) within a fiberoptic's core 66, cladding 68, and the core/cladding boundary 80. Witheach of the exemplary embodiments depicted microscopic structures 117are dispersed within the insertable optical element 14 (in this case anoptical fiber) to achieve radial transmission of light. Thesemicroscopic structures 117 may be positioned within the core 66 and/orat the core-cladding boundary 80 and/or within the cladding 68 of theoptical fiber 14. The microscopic structures 117 having a refractiveindex lower than the region free of microscopic structures 117. Themicroscopic structures 117 may be a material added to the optical fibercore 66 or the core-cladding boundary 80, such as a metal, rubber, glassbeads, or plastic. The microscopic structures 117 may also be the lackof material creating an aberration within the optical fiber core 66and/or the core-cladding boundary 80 and/or within the cladding 68. Forexample, the presence of microscopic structures 117 (such as bubbles) inthe optical fiber core 66 creates an aberration or imperfection thatwould alter the materials refractive index, resulting in EMR beingemitted radially from the optical fiber (insertable optical element 14).

In FIG. 11, three exemplary dispersals, a first dispersal 121, a seconddispersal 123, and a third dispersal 125, are depicted. The firstdispersal 121 has microscopic structures 117 (such as flecks or bubbles)dispersed within and outer region 127 of the core 66 only. The seconddispersal 123 has microscopic structures 117 dispersed within an innerregion 129 of the cladding 68 as well as within the outer region 127 ofthe core 66. The third dispersal 125 has microscopic structures 117dispersed proximate to the core/cladding boundary 80 and are depicted asidentifying a boundary region 131 that is thinner than the outer region127 of the core 66 and the inner region 129 of the cladding 68. Witheach of these exemplary dispersals, at least some of the light travelingthe length of the insertable optical element 14 (fiber optic) will notencounter any microscopic structures 117 while the remainder of thelight may encounter at least one microscopic structure 117 and bedeflected to emit radially from the insertable optical element 14.

FIG. 12 is a schematic view of an exemplary optical element modificationmethod for creating gradient modification on the exterior surface 62 ofthe insertable optical element 14. Such modification of the core 66 oroptical element cladding 68 alters the incident angle of light rays sothat they differ from the critical angle needed to remain internallyreflected. Depicted in FIG. 12 is a control device 122 with a wand 124delivering an acid spray 126 for etching the insertable optical element14.

There are several methods for achieving this gradient modification.Chemically, the insertable optical element 14 may be etched using astrong acid such as hydrofluoric acid or sulfuric acid andhydrogen-peroxide. Also, quartz powder, calcium fluoride, or an etchingcream, usually carrying a fluorinated compound, may be used. Physically,heating the insertable optical element 14 or physical modification suchas ablation by sanding, media blasting, grinding, or laser ablationmodifications are also methods for creating gradient modification.Additionally, plasma ablation by laser modification causes theionization of molecules and alteration of the exterior surface 62 of theinsertable optical element 14. Other known methods for creating gradientablation are contemplated by this disclosure. Regardless of themodification or manufacturing process, whether presently known or not,the insertable optical element 14 may be modified to have substantiallyequivalent radially emitted light along desired lengths. This uniformityin radially emitted light allows for a more accurate treatment dose forinactivating infectious agents and/or promoting healing.

In FIGS. 8A-D, 9, and 12 of the present disclosure, a transparent viewof the optical element connector 94 is depicted, comprising a connectingelement 88, an EMR hub connection 90, a collimating lens 92, and analignment shaft 98. The insertable optical element 14 may be insertedinto an aligning bore of the optical element connector 94 to collimatethe light into a small diameter core 66 or one or more optical fibers.

The exemplary disclosure depicts an optical diversion element as asingle collimating lens 92, but other types of optical diversionelements such as multiple lenses or different types of lenses may beused to collimate the light. Depending on the optical element 14diameter, numerical aperture, and refractive index, specific lenses willbe needed as an optical diversion element to reduce light loss.

Turning now to FIG. 13, a urinary catheter assembly is depicted. Theurinary catheter assembly comprises and electromagnetic radiationcomponent 20 and an insertable catheter component 22. The insertablecatheter component comprises a proximal catheter hub assembly 32, anelongate catheter body 36 and a distal end 34 region. The proximalcatheter hub assembly 32 serves as an input port 43 (the arrow showingthe direction of fluid flow and/or therapeutic EMR propagation 162). Theelongate catheter body 36 also comprises an output port 45 for drainingurine from the patient (the arrow showing the direction of urine flow164), an inflatable balloon cuff 37 (shown inflated), and an aperture35, the balloon cuff 37 and aperture 35 are disposed within the distalend 34 region. The insertable catheter component 22 may be made invarying lengths 38 as female urinary catheters are typically shorterthan male urinary catheters which are made to different lengths.

The electromagnetic radiation component 20 comprises an EMR power source26, a coupling element 28, and an optical element 14. As depicted, thecoupling element 28 is spaced from the catheter hub assembly 32 toreveal the optical element 14 that is partially inserted into the lumenof the elongate catheter body 36. When the coupling element 28 isconnected to the catheter hub assembly 32, the optical element will befully inserted and the distal end of the optical element 14 will extendto the termination 42 so not to interfere with the inflatable ballooncuff 37 or the aperture 35. In this fully inserted disposition, theoptical element 14 may emit radially therapeutic EMR at the incisionsite A and into the transdermal area 48.

FIG. 14 depicts another exemplary urinary catheter 10 as positionedwithin a male patient. As shown, the urinary catheter 10 has beeninserted into the patient's bladder 41 through the urethra 39 and theballoon cuff 37 has been inflated to seal the bladder 41 from leakingaround the urinary catheter 10. This exemplary urinary catheter 10comprises an elongate catheter body 36, an adapter 150, a securingsleeve 152, and a drain tube 154. The adapter 150 has an input port 43and an output port 45. An EMR component 20 may be utilized inconjunction with the exemplary urinary catheter 10 to providetherapeutic EMR along the urethra 39 and into the bladder 41 toinactivate infectious agents and/or to promote healthy cell growth. TheEMR component 20 comprises a control device 154 that houses an EMR powersource 26, operational control features 156 and a display 158, anoptical element 14, and an optical jack 160.

When positioned as shown in in FIG. 14, the optical element 14 has beenthreaded into the adapter 150 and secured by the securing sleeve 152 andurine freely drains through the elongate body 36 into the drain tube 154to be deposited in a urine drain bag (not shown). Frequently, urinarycatheters 10 are indwelling for long periods of time and consequentlyare a concern for the build-up and proliferation of infectious agents inor around the urinary catheter 10. To provide therapeutic EMR toprevent, reduce, or eliminate the proliferation of infectious agentsand/or to enhance healthy cell growth, the optical jack 160 is pluggedinto the control device 154 connecting the optic al element 14 to theEMR power source 26 and the operational control features 156 areactivated to set the frequency or frequencies, intensity, power, dutycycle, and other operational parameters, and turn on the EMR deliveryinto the optical element 14. The setting of the operational features andthe monitoring of the parameters may be viewed on the display 158.

For exemplary methods or processes of the invention, the sequence and/orarrangement of steps described herein are illustrative and notrestrictive. Accordingly, it should be understood that, although stepsof various processes or methods may be shown and described as being in asequence or temporal arrangement, the steps of any such processes ormethods are not limited to being carried out in any particular sequenceor arrangement, absent an indication otherwise. Indeed, the steps insuch processes or methods generally may be carried out in variousdifferent sequences and arrangements while still falling within thescope of the present invention.

Additionally, any references to advantages, benefits, unexpectedresults, or operability of the present invention are not intended as anaffirmation that the invention has been previously reduced to practiceor that any testing has been performed. Likewise, unless statedotherwise, use of verbs in the past tense (present perfect or preterit)is not intended to indicate or imply that the invention has beenpreviously reduced to practice or that any testing has been performed.

Exemplary embodiments of the present invention are described above. Noelement, act, or instruction used in this description should beconstrued as important, necessary, critical, or essential to theinvention unless explicitly described as such. Although severalexemplary embodiments have been described in detail herein, thoseskilled in the art will readily appreciate that many modifications arepossible in these exemplary embodiments without materially departingfrom the novel teachings and advantages of this invention. Accordingly,all such modifications are intended to be included within the scope ofthis invention as defined in the appended claims.

In the claims, any means-plus-function clauses are intended to cover thestructures described herein as performing the recited function and notonly structural equivalents, but also equivalent structures. Thus,although a nail and a screw may not be structural equivalents in that anail employs a cylindrical surface to secure wooden parts together,whereas a screw employs a helical surface, in the environment offastening wooden parts, a nail and a screw may be equivalent structures.Unless the exact language “means for” (performing a particular functionor step) is recited in the claims, a construction under Section 112, 6thparagraph is not intended. Additionally, it is not intended that thescope of patent protection afforded the present invention be defined byreading into any claim a limitation found herein that does notexplicitly appear in the claim itself

While specific embodiments and applications of the present inventionhave been illustrated and described, it is to be understood that theinvention is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent invention disclosed herein without departing from the spirit andscope of the invention.

What is claimed is:
 1. A medical device assembly for insertion into acavity of a patient's body and for delivery of a fluid to and/orretrieval of fluid from the patient's body, comprising: anelectromagnetic radiation (EMR) source for providing non-ultraviolet,therapeutic EMR having an intensity comprising a radiant exposure of atleast 0.1 J/cm ² and up to 1.0 kJ/cm² and power of at least 0.005 mW andup to 1 Watt, such intensity being sufficient to produce a therapeuticeffect of at least one of inactivating one or more infectious agents andenhancing healthy cell growth; a catheter having an elongate catheterbody with at least one internal lumen, a coupling end and a distal end,the distal end being insertable into the cavity of the patient's body,wherein the catheter body directs both the fluid and the therapeutic EMRaxially relative to the catheter body, axial flow of the fluid withinthe catheter body facilitates at least one of delivery of fluid into thepatient's body and retrieval of fluid from the patient's body; anoptical element conducive to the axial propagation of the therapeuticEMR relative to the catheter body, the optical element having a positionwith respect to the catheter body of being within at least one internallumen of the catheter body; and at least one coupling to connect the EMRsource to the catheter body.
 2. The medical device assembly as in claim1 wherein the catheter body is configured for access to at least onecavity of the patient's body, such cavity being at least one of avenous, an arterial, a gastrointestinal, an abdominal, a urological, arespiratory, a cranial, and a spinal cavity.
 3. The medical deviceassembly as in claim 1 wherein the at least one internal lumen comprisesa propagation lumen for the axial propagation of the therapeutic EMRrelative to the catheter body.
 4. The medical device assembly as inclaim 1 wherein the optical element is selected from a group of opticalelements including a reflective surface, a lens, a fiber optic filament,and any combination thereof.
 5. The medical device assembly as in claim1 wherein at least a portion of the optical element comprises a fiberoptic filament for disposition within the at least one internal lumen,the fiber optic filament comprises a fiber body having at least aportion configured as at least one of a bare fiber body and acladding-encased fiber body, the fiber body having an exterior surface,a coupling end, a distal end, and a core, the fiber optic filament beingconducive to the axial propagation of therapeutic EMR within the core.6. The medical device assembly as in claim 5 wherein the fiber opticfilament further comprises at least one radial emission portion on theexterior surface disposed between the coupling end of the fiber body andthe distal end of the fiber body, the radial emission portion allowingthe emission of therapeutic EMR radially from the fiber body into thelumen of the catheter.
 7. The medical device assembly as in claim 6wherein the catheter has at least a portion of at least translucencyallowing the therapeutic EMR radially emitted from the fiber body topass through the catheter into one or more infectious agents exterior tothe catheter for inactivation of the infectious agents located in atleast one of on the catheter, on tissue within the patient's bodysurrounding the catheter, and within tissue of the patient's bodysurrounding the catheter.
 8. The medical device assembly as in claim 6wherein at least one radial emission portion-directs therapeutic EMR ofa desired intensity radially through and along the length of each radialemission portion into the internal lumen of the catheter.
 9. The medicaldevice assembly as in claim 8 wherein the radial emission portioncomprises an ablated surface, the ablated surface having a gradientablation, the gradient ablation having a gradient pattern such that theemission of EMR radially from the radial emission portion has a uniformintensity.
 10. The medical device assembly as in claim 1 wherein thetherapeutic EMR has a wavelength that ranges from about 380 nm to about904 nm.
 11. The medical device assembly as in claim 5 wherein theinternal lumen has an inner diameter and the fiber body has an outerdiameter, the inner diameter of the internal lumen being greater thatthe outer diameter of the fiber body, thereby defining a void within theinternal lumen external to the exterior surface of the fiber body. 12.The medical device assembly as in claim 11 wherein the void facilitatesthe passage of fluid through the void by at least one of delivery offluid to and retrieval of fluid from the patient's body simultaneouslywith at least a portion of the fiber body being disposed within theinternal lumen.
 13. The medical device assembly as in claim 11 whereinat least a portion of the optical element is removably insertable intothe internal lumen.
 14. The medical device assembly as in claim 1wherein the catheter is selected from a group including a central venouscatheter, a peripheral insertion catheter, a peripheral insertioncentral catheter, a midline catheter, a jugular catheter, a subclaviancatheter, a femoral catheter, a cardiac catheter, a cardiovascularcatheter, a urinary catheter, an intermittent urinary catheter, anendotracheal tube, a hemodialysis catheter, a peritoneal dialysiscatheter, a gastrointestinal catheter, a nasogastric tube, and a wounddrainage catheter.
 15. A medical device assembly for insertion into acavity of a patient's body and for delivery of fluid to and/or retrievalof fluid from the patient's body, comprising: an electromagneticradiation (EMR) source selected from a group including a solid statelaser, a semiconductor laser, a diode laser, and a light emitting diode,the EMR source for providing non-ultraviolet, therapeutic EMR having awavelength in a range of above 380 nm to 904 nm and having an intensitycomprising a radiant exposure of at least 0.1 J/cm² and up to 1.0 kJ/cm²and power of at least 0.005 mW and up to 1.0 Watt, such intensity beingsufficient to produce a therapeutic effect of at least one ofinactivating one or more infectious agents and enhancing healthy cellgrowth; a catheter having an elongate catheter body with at least oneinternal lumen, a coupling end and a distal end, the distal end beinginsertable into the cavity of the patient's body, wherein the catheterbody directs both the fluid and the therapeutic EMR axially relative tothe catheter body for at least one of delivery of fluid into thepatient's body and retrieval of fluid from the patient's body; anoptical element conducive to the axial propagation of the therapeuticEMR relative to the catheter body, the optical element having a positionwith respect to the catheter body of being within at least one internallumen of the catheter body; and at least one coupling to connect theradiation source to the catheter body.
 16. The medical device assemblyas in claim 15 wherein the wavelength of the therapeutic EMR is selectedfrom a group of wavelengths including wavelengths centered about 400 nm,405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm,632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830nm, and 904 nm.
 17. The medical device assembly as in claim 16 whereinthe therapeutic EMR comprises one or more of the selected wavelengthsbeing emitted in at least one of alternating and parallel treatmentpatterns.
 18. The medical device assembly as in claim 15 wherein thecatheter is selected from a group including a central venous catheter, aperipheral insertion catheter, a peripheral insertion central catheter,a midline catheter, a jugular catheter, a subclavian catheter, a femoralcatheter, a cardiac catheter, a cardiovascular catheter, a urinarycatheter, an intermittent urinary catheter, an endotracheal tube, ahemodialysis catheter, a peritoneal dialysis catheter, agastrointestinal catheter, a nasogastric tube, and a wound drainagecatheter.
 19. A medical device assembly for insertion into a cavity of apatient's body and for delivery of fluid to and/or retrieval of fluidfrom the patient's body, comprising: an electromagnetic radiation (EMR)source for providing non-ultraviolet, therapeutic EMR having awavelength in a range of above 380 nm to 904 nm and having an intensity